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How Stakeholders are Affected by FDA’s New Naming Convention for Biologics and Biosimilars

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By Pooja Babbrah, Senior Consultant

Pharmacy AutomationStakeholders across the industry are debating potential costs and burden associated with implementing the new, nonproprietary naming convention for biologics and biosimilars. Requirements for the changeover were spelled out in January 2017 guidance from the Food and Drug Administration (FDA). You can read more about the content of the guidance in my previous blog post.

Going forward, all biologics and biosimilars will have a unique, non-proprietary name that is a combination of the drug’s core name and a distinguishing suffix that is devoid of meaning and composed of four lowercase letters (e.g. infliximab-dyyb). These requirements apply to both newly licensed biologics and biosimilars, and will also be applied retrospectively to biologics already on the market.

According to the FDA, the new naming convention seeks to: 1) help prevent inadvertent substitution (which could lead to medication errors) of biological products that are not determined to be interchangeable by the FDA; and 2) support safety monitoring of all biological products after they are on the market, by making it easier to accurately track usage of biological products in all settings of care, including outpatient, hospital, and pharmacies, and trace adverse events back to the manufacturer and batch.

While all stakeholders appreciate the FDA’s concerns, some argue that these changes will result in unnecessary costs, burden and other issues. For example, the National Council for Prescription Drug Programs (NCPDP) believes the “FDA’s new naming convention arises from an incomplete awareness of the comprehensive electronic programming, which underlies how drugs are prescribed and dispensed.” This infrastructure – largely due to federal efforts over nearly a decade to promote health information technology – is now pervasive. As a result, the changeover in systems by the new naming convention could be costly and burdensome to implement, NCPDP and some of its members argue. Some also fear unintended consequences. One of the most significant examples is potential payment delays created while all public and private payers retrofit their systems and formularies to accommodate the renaming of every biological drug, including those that have been marketed for years under a different nonproprietary name.

To better understand the impact of the FDA’s new naming convention, Point-of-Care Partners (POCP) conducted in-depth interviews with key staff from drug data compendia; vendors and users of electronic health records (EHRs) and computerized physician order entry (CPOE) systems; pharmacists; and a pharmacy system vendor. Findings showed that the implementation of the guidance will, indeed, impact the industry, especially as it relates to existing biologics on the market and, in most cases, stakeholders will be required to make some coding changes, system retrofits and other adaptations to accommodate the change. However, the extent of the impact is stakeholder-specific and will also depend upon the total number of drugs which will truly be impacted by the guidance. Here are some of our findings.

Changes occur in today’s market and are handled successfully. POCP’s research showed that the implementation of the guidance might not be as burdensome or costly as some stakeholders had suggested. One reason is that the industry is used to making numerous changes in their systems related to the drugs used today. For example, changes often occur to National Drug Code (NDC) numbers, product descriptions and therapeutic classifications, not to mention product name changes. In our discussions with EHR vendors and pharmacists, all stated that they successfully manage these types of changes today with minimal impact on day-to-day operations. There are established methods to address these market changes. Therefore, changes to address the new naming convention for biologics and biosimilars are nothing new in that respect. However, many of the concerns voiced by industry relate to the total number of products that might be impacted by the new requirements. DailyMed lists roughly 15,000 NDCs. The sheer volume of potential changes is a significant concern.

Scope of the guidance. At this point, it is unclear whether the FDA’s guidance applies to every US product with an approved Biologics License Application (BLA) or only to those on the Center for Drug Evaluation and Research (CDER) List of Licensed Biological Products. To be sure, the answer to this will directly impact costs and burden. If the final rule applies solely to the those on the CDER list, it would affect name changes for only 131 products representing approximately 900 NDCs[1], as opposed to thousands that were referenced in many of the comments and concerns voiced to the FDA during the comment period on the guidance. The total number of NDCs affected could be much less if a name change applies only to products that have proposed multiple sources.

Impact on specific stakeholders. The impact of the FDA’s new guidance is largely situational for the following stakeholder groups:

  1. Drug Compendia. The new guidance will have the greatest impact on drug compendia as they will have the most work to retrofit systems. These companies believe the new naming requirement is unnecessary because their current algorithms and processes already accomplish what the FDA hopes to achieve, namely preventing inadvertent substitution, tracking biologics through the ecosystem and tracing adverse events back to the manufacturer. Compendia currently follow a specific process for creating the files and databases used by EHRs, hospital information systems (HIS) and pharmacy system vendors. As part of it, compendia vendors group similar products using specific identifiers, including INN, strength, and dosage form. This process of grouping drugs will likely be impacted by the guidance. For example, compendia will need to recreate links between old and new generic names for all products; update the data they provide to clients and potentially introduce different files and processes for biologics. This could impact their clients as there are many variations in how their files are currently implemented at various vendors and institutions. For the compendia themselves, current research estimates that the coding changes necessary to accommodate the addition of an FDA approved suffix could take up to 50 hours per product[2]. However, if compendia can handle these products in a similar manner as they do today, there will be less of an impact on both their own operations and to their client base.

The drug database companies believe that there is no reason to change this current process and the introduction of this new naming convention will simply cause unneeded confusion among prescribers. Some went so far as to argue that using suffixes will lead to higher prescribing of source medications, thus defeating the cost-saving purpose of introducing biosimilars. Furthermore, compendia executives we spoke with argue that the proposed naming convention will not help improve the ability to track and trace an adverse event, but that is better handled through existing processes. These include capturing and storing the accurate dispensed medication data in all of the systems involved with the medication prescribing and dispensing process. At the end of the day, the costs and impacts to compendia will be based on the total volume of NDCs impacted, including any potential changes needed to regroup and/or implement indicators of the biosimilar and biologic reference product relationships.

  1. Electronic health records (EHRs). According to the ambulatory and acute EHR vendors and their users that we spoke with, name changes for biologics and biosimilars would have minimal to no impact on their systems and operations. Today, most EHR vendors will take the file(s) that compendia provide, run a quality check on the file and prepare it for loading into their system. Updates to the drug file appear in the EHR anywhere between 2 weeks and 6 months depending upon the configuration of the EHR and the timing of when a practice updates their database[i]. Because NDC and name changes happen today, most felt there would be limited impact in terms of cost and resources to handle these changes. That said, EHR vendors should pay attention to the FDA’s guidance and any communications from the drug compendia related to this topic. Due to the large number of NDCs that may be impacted by the FDA’s guidance; for example, it would be prudent for EHR vendors to take the time to review the files in more detail. Also, depending upon how the drug compendia choose to handle the changes, additional programming may be needed for the EHR vendor to link old and new NDCs, and the biologics may end up being provided in a separate file for the EHR vendor to download. If this is the route taken by the compendia vendors, the impact to EHRs would be greater than they are anticipating today.

The other area identified that may impact EHRs is the messaging to the provider when an electronic refill message is sent from the pharmacy to the provider. If a name change occurs and the linkage between the old and new name has not been made in the drug file, it may appear to the provider that the drug is no longer available for prescribing when, in fact, it is simply a name change for the drug. At the end of the day, EHR vendors should focus on taking the extra time to thoroughly review changes to the compendia files and reviewing the links to ensure proper messages are being provided to the prescriber regarding the name change. This is highly recommended as a best practice, which is better implemented sooner rather than later.

  1. Pharmacy (Retail, Mail, Specialty, Long-term Care). The pharmacy stakeholders we spoke with don’t anticipate that a name change alone for biologics and biosimilars will have substantial impact on pharmacy operations. Like the EHR vendors, pharmacy system vendors use the compendia files, which link products into appropriate groups and thus can be used to identify similar products and provide a guide for substitution. Additional time and resources will likely be needed to quality check the files due to the potentially large number of changes.

The greater impact to the pharmacy staff and systems is related to the back-end processes, as opposed to the front-end dispensing of the drug. The FDA guidance addresses name change only and does not indicate if an NDC change must occur along with the name change.  If an NDC change occurs along with a name change, billing and inventory management may be impacted during the transition period from old to new NDC. It is likely that there will be a transition period in which a pharmacy would have inventory with both the old and new NDC numbers. Any billing of product during that time would have to be carefully reviewed to ensure that the pharmacy is billing for the NDC number that was dispensed. There would be no programming changes required related to this issue because these are primarily process and operations changes to ensure that the name and/or NDC changes are clearly communicated to staff to ensure the correct billing of existing inventory during the transition period.

  1. Hospitals, Clinics, Infusion Centers and related facilities. For the most part, a name change alone will have limited impact on existing ambulatory and hospital electronic prescribing systems for the same reasons we have stated above: changes to product names and NDCs occur today and are handled by all stakeholders. However, discussions with users of CPOE systems in hospitals revealed that their main concern was related to how ancillary systems would need to be integrated with their EHR or CPOE system, such as lab and radiology software integrations. In reality, the vendors and facilities have no control over what changes may be needed in the application program interfaces (or APIs) that are used by add-on products to the primary EHR or CPOE systems. Facilities could experience a bigger impact if a name or NDC change requires significant alterations to interfaces or if updates are needed to APIs.

Bringing it all together. Through our research and interviews with stakeholder groups, we determined that the guidance provided by the FDA around biologic and biosimilar naming will have an impact on all stakeholders in the industry. However, the extent of the impact depends upon the volume of products involved as well as the extent of the change (i.e., name only or name and NDC number). The consensus from the industry stakeholders we spoke with was that the guidance will likely pertain to the smaller list of drugs – those on the CDER list versus all US products with an approved BLA. Point-of-Care Partners has been keeping on top of this issue. Let us know if you would like more information. We’d be happy to do a deeper dive for you on the market impacts of the FDA’s new guidance and our research. Contact me at pooja.babbrah@pocp.com.

[1] Source: Number of BLAs from FDA website, dated 6/1/2017; https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/UCM560162.pdf)

[2] Source: Multiple Stakeholder comments on FDA Nonproprietary Naming of Biological Products Guidance; accessed here: https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2013-D-1543

[i] Primary Research: POCP tracking over 100 Pharma drug launches in EHRs

Pooja Babbrah

Pooja Babbrah

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